Organ system
|
Severe
|
Moderate
|
Mild
|
Total
|
---|
Any
|
1 (3.3)
|
8 (26.7)
|
17 (56.7)
|
19 (63.3)
|
Gastrointestinal
|
1 (3.3)
|
4 (13.3)
|
12 (40.0)
|
13 (43.3)
|
General and
|
0
|
5 (16.7)
|
9 (30.0)
|
10 (33.3)
|
injection site
|
Neurological
|
0
|
0
|
3 (10.0)
|
3 (10.0)
|
Metabolic and nutritional
|
0
|
1 (3.3)
|
1 (3.3)
|
2 (6.7)
|
Infections
|
0
|
1 (3.3)
|
0
|
1 (3.3)
|
Skin and subcutaneous tissue
|
0
|
0
|
1 (3.3)
|
1 (3.3)
|
Ear and labyrinth
|
0
|
0
|
1 (3.3)
|
1 (3.3)
|
Renal/urinary tract
|
0
|
1 (3.3)a
|
0
|
1 (3.3)
|
Reproductive system and breast
|
0
|
0
|
1 (3.3)
|
1 (3.3)
|
Vascular
|
0
|
0
|
1 (3.3)
|
1 (3.3)
|
- Data are number (%) of patients.
-
aEvent was serious AE (acute renal failure) but resolved without sequelae.